Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane Anesthesia for Major Spine Surgery Under Somato Sensory- and Motor- Evoked Potential Monitoring

Last updated: January 6, 2024
Sponsor: Ain Shams University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Orthopedics

Treatment

Propofol-Fentanyl-Dexmedetomidine

Propofol-Fentanyl

Propofol-Fentanyl-Sevoflurane

Clinical Study ID

NCT06210061
FMASU MD206/2023
  • Ages 21-45
  • All Genders

Study Summary

The objective of this study is to evaluate the effect of adding dexmedetomidine on evoked potentials in adult patients undergoing spinal surgery under intravenous anesthesia

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age from 21-45 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status I and II.
  • Undergoing major spine surgery

Exclusion

Exclusion Criteria:

  • Refusal of procedure or participation in the study by patients.
  • Patients with known history of allergy to one of study drugs
  • Patients with nerve conduction pathway injury.
  • Severe circulatory or respiratory disease.
  • Cognitive or psychiatric illness that leads to inability to cooperate, speak orprovide informed consent
  • Patients with history of Myasthenia gravis, epilepsy , history of pacemakerimplantation .
  • Patients who need to be awakened during the procedure.

Study Design

Total Participants: 78
Treatment Group(s): 3
Primary Treatment: Propofol-Fentanyl-Dexmedetomidine
Phase:
Study Start date:
September 01, 2023
Estimated Completion Date:
September 01, 2024

Study Description

A catastrophic complication of spinal surgery is nerve and spinal cord injury. The incidence of neurological defects after spinal surgery can be reduced from 3.7%-6.9% to less than 1% with proper electrophysiological monitoring.

Somatosensory evoked potentials (SEPs) and motor evoked potentials (MEPs) are currently used as adjunct diagnostic methods in spinal surgery, such as scoliosis surgery and spinal stenosis decompression.

Total intravenous anesthesia (TIVA) with propofol and opioids is commonly used in SEPs and MEPs monitoring as it causes increase in latency in comparison to inhalational anesthetics that cause decrease in amplitude .

The amplitudes of MEPs and SEPs are reduced by halogenated volatile anesthetics, limiting their use in spinal surgery that requires electrophysiological monitoring. When volatile anesthetics did not exceed 0.3MAC, they had little effect on MEPs and SEPs . Martin et al. discovered that volatile agent-based anesthesia has application value during neurophysiological monitoring, such as faster awakening and rapid wake-up tests.

As well, volatile anesthetics can reduce the dosage of propofol. As a result, spinal surgery benefits from combined intravenous inhalation anesthesia. As an adjuvant, dexmedetomidine may be useful in reducing the need for propofol.

Dexmedetomidine is a potent and highly selective alpha-2 agonist. It has the effect of sedation, analgesia, sympatholytic, minimal respiratory depression and possible neuroprotection. Its addition to the anesthetic regimen is believed to have the potential of sparing other hypnotics requirement, especially propofol, thus facilitating MEP and SSEP monitoring while providing the beneficial effects it has.

Connect with a study center

  • Ain Shams University

    Cairo, 11591
    Egypt

    Active - Recruiting

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